Head and Neck NeoplasmsNCT05227807
The Efficacy of Mouth Exercise in Oral Cancer Patients After Receiving Surgery
A study testing mouth opening exercise in people with Head and Neck Neoplasms, run by National Taipei University of Nursing and Health Sciences.
Trial summary
PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer. METHODS: The study is a quasi-experimental design using repeated measures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- mouth opening exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- 7 Jul 2012to 12 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- have a clear consciousness
- can communicate in Mandarin and Taiwanese
- diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and
- undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction
- radiation and/or concurrent chemotherapy.
Who cannot join
- Poor wound healing after surgery and unable to perform the oral movement
- no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured
- those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)
About this study
Official title: The Efficacy of Mouth Exercise for Preventing Trismus in Oral Cancer Patients After Receiving Surgery and Radio or Chemotherapy
PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer.
METHODS: The study is a quasi-experimental design using repeated measures. 44 patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited to the control group first then 38 patients were recruited to the intervention group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months and two telephone calls fellow up. Subjects in the intervention group received mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one month, three months, and six months after radiotherapy, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire, Restriction of Mouth Opening Questionnaire, and Difficulty of Food Intake.
Read the detailed description
The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.
The study is a quasi-experimental design with repeated measures. A convenience sample of 44 oral cancer patients was recruited to control group the 38 patients was recruited to the intervention group Subjects in the control group received routine care including written mouth exercise instructions. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Patients in the experimental group were provided with two one-on-one oral exercise instruction courses after receiving the last two radiation treatments by nurse practitioner. Subjects in the intervention group received additional 2 follow-up phone calls from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, three-months and six month after radiotherapy, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.
All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).
- Conditions
- Head and Neck Neoplasms
- Being tested
- mouth opening exercise, Usual care
- Keywords
- oral cancer, Trismus, Mouth-opening training, Maximum interincisal opening, Follow-up telephone calls, Mandibular function
- Medical subject headings
- Head and Neck Neoplasms, Mouth Neoplasms, Trismus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mouth opening exerciseBehavioural
The intervention group receives an oral exercise intervention, including a 30-minute individual training, a multimedia oral exercise education video along with a print education booklet, and three follow-up phone calls.
Usual careBehavioural
routine care including written mouth exercise instructions
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | the control group received routine care. Receives: Behavioral: Usual care |
| Intervention group | Experimental | Intervention develop from the theoretical framework of social cognition theory Receives: Behavioral: mouth opening exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
MIO( Maximum inter-incisal opening)
With the disposable oral activity scale (The TheraBite Range-of-Motion Scales), patients are asked to open their mouths as wide as possible while sitting on a chair. The TheraBite Range-of-Motion Scale was used to measure MIO with the subject in an upright position. Subjects with MIO <35 mm were considered to have trismus. The scale was measured by mm. For all values of mouth opening from 20 to 50 mm.The higher the score, the mouth is open.
Measured: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Secondary outcomes (3)
Restriction of Mouth Opening Questionnaire
There are 10 questions in the questionnaire. The content includes the restriction on eating, speaking, cleaning, and inspection of the oral cavity. Each question is scored on a Likert scale with a score of 1-5. The average score of each question is the total score of the scale. The higher the score, the mouth is open. The higher the degree of restriction. Chinese translation version of the questionnaire, the expert validity of each question content validity index score is greater than 0.8, for oral cancer patients (n = 60) Cronbach's α is 0.96
Measured: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Mandibular Function Impairment Questionnaire
There are 17 questions, including the difficulty of chewing hard and soft foods, taking a big bite of food, laughing, eating specific foods, social activities, speaking, etc. Each question is scored on the Likert scale of 0-4 points. The scores of each question are added and divided by 68 to convert to a total score of 0-1 points. The higher the score, the more severe the functional impairment.
Measured: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Exercise Time
oral exercise practicing time recoded by participants by time of exercise. Time is calculated in minutes
Measured: each week during the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start7 Jul 2012
- Primary completion30 Oct 2014
- Study completion12 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Medical Foundation
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- SuFan Wu, Doctor, Study director, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227807
- Sponsor's protocol ID
- 100-4007A3
- Status last verified
- Feb 2022
- First submitted
- 12 Dec 2021
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Mouth Exercise for Preventing Trismus in Oral Cancer Patients After Receiving Surgery and Radio or Chemotherapy
- ClinicalTrials.gov ID
- NCT05227807
- Acronym / sponsor ID
- 100-4007A3
- Conditions
- Head and Neck Neoplasms
- Keywords
- oral cancer, Trismus, Mouth-opening training, Maximum interincisal opening, Follow-up telephone calls, Mandibular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Chang Gung Medical Foundation
- Study start
- 7 Jul 2012 (actual)
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 12 Dec 2014 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PURPOSE: The purpose of the study was to investigate the efficacy of mouth-opening training with follow-up on 1st、3rd、6th months for reducing postoperative trismus in patients with oral cancer.
METHODS: The study is a quasi-experimental design using repeated measures. 44 patients admitted at a general hospital in Taiwan for oral cancer surgery were recruited to the control group first then 38 patients were recruited to the intervention group. All subjects were instructed to practice mouth-opening exercises three times a day every day for three months and two telephone calls fellow up. Subjects in the intervention group received mouth-opening exercise adherence. Data on maximum interincisal opening and mandibular function impairment were collected before surgery, at one month, three months, and six months after radiotherapy, using the TheraBite Range-of-Motion scale and Mandibular Function Impairment Questionnaire, Restriction of Mouth Opening Questionnaire, and Difficulty of Food Intake.
Detailed description
The purpose of the study was to investigate the effect of mouth-opening exercise training with follow-up telephone calls for preventing postoperative trismus in patients with oral cancer. The specific aims were to test the intervention effects on enhancing mouth-opening exercise practice, MIO, and mandibular function. We hypothesized that the intervention group would show 1) better adherence to mouth-opening exercises, 2) greater MIO, and 3) better mandibular function over time, compared to the control group.
The study is a quasi-experimental design with repeated measures. A convenience sample of 44 oral cancer patients was recruited to control group the 38 patients was recruited to the intervention group Subjects in the control group received routine care including written mouth exercise instructions. Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Patients in the experimental group were provided with two one-on-one oral exercise instruction courses after receiving the last two radiation treatments by nurse practitioner. Subjects in the intervention group received additional 2 follow-up phone calls from the interventionist to enhance mouth-opening exercise adherence. Data on MIO and mandibular function impairment were collected before surgery, at one-month, three-months and six month after radiotherapy, using the TheraBite Range-of-Motion scale and the Mandibular Function Impairment Questionnaire. The study was approved by the research ethics committee of the hospital where the data were collected.
All statistical analyses were carried out using the SPSS statistical package version 20.0 (SPSS Inc., Chicago, IL, USA). Characteristics of the subjects were summarized by percentages, means, and standard deviations (SDs). Chi-squared tests or Fisher's exact tests and two independent samples t-tests were used to examine group baseline equivalency. Value changes of study outcomes (MIO and mandibular function impairment) and mouth-opening exercises performed from T1, T2, to T3 were expressed in two study groups. A general linear model was used to model these outcomes as a function of main group effect and main time effect. An interaction term (group difference by time) was added into each model to investigate the synergistic effect of the intervention with time. Both the stability analysis and the analysis of repeated relationships were performed by generalized estimation equations (GEE).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Usual carethe control group received routine care. |
| Intervention group | Experimental | Behavioral: mouth opening exerciseIntervention develop from the theoretical framework of social cognition theory |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Over 18 years old
- have a clear consciousness
- can communicate in Mandarin and Taiwanese
- diagnosed by a doctor as primary oral cancer (including gums, the floor of the mouth, buccal mucosa, hard palate, and posterior molar area) and
- undergoing oral cancer tumor resection (including upper lymphatic removal) Those who have undergone skin flap reconstruction
Key exclusion criteria (3 listed)
- Poor wound healing after surgery and unable to perform the oral movement
- no incisor or the position of the incisor after surgery is replaced by a flap due to surgery, the maximum opening distance cannot be measured
- those with lip and tongue cancers that are less related to the closure of the teeth ( Or those who are physically unable to exercise)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mouth opening exerciseThe intervention group receives an oral exercise intervention, including a 30-minute individual training, a multimedia oral exercise education video along with a print education booklet, and three follow-up phone calls. | Behavioural | Intervention group |
| Usual careroutine care including written mouth exercise instructions | Behavioural | Control group |
Primary outcome
MIO( Maximum inter-incisal opening)
Time frame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
With the disposable oral activity scale (The TheraBite Range-of-Motion Scales), patients are asked to open their mouths as wide as possible while sitting on a chair. The TheraBite Range-of-Motion Scale was used to measure MIO with the subject in an upright position. Subjects with MIO <35 mm were considered to have trismus. The scale was measured by mm. For all values of mouth opening from 20 to 50 mm.The higher the score, the mouth is open.
3 secondary outcomes
Restriction of Mouth Opening Questionnaire
Time frame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Mandibular Function Impairment Questionnaire
Time frame: Change from pre-intervention and during the intervention on 2, 4, and 6 months
Exercise Time
Time frame: each week during the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SuFan Wu, Doctor study director
National Taipei University of Nursing and Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing mouth opening exercise in people with Head and Neck Neoplasms, run by National Taipei University of Nursing and Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MIO( Maximum inter-incisal opening) (time frame: Change from pre-intervention and during the intervention on 2, 4, and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.